• FDA Slashes Fees for Priority Review Voucher

    The US Food and Drug Administration (FDA) has announced the release of fee rates for using tropical disease priority review vouchers for the upcoming year, slashing fees more than 32% from 2012. The tropical disease voucher system was established under the FDA Amendment Act of 2007 (FDAAA) , which authorized a novel program. Under it, companies that receive approval for a tropical disease treatment are eligible to receive a transferrable voucher that allows the bear...
  • Post-FDAAA, Regulators Move to Adapt to Changing Risk Models

    With all the attention given to the US Food and Drug Administration's (FDA) approval process, it can sometimes be easy to forget an equal amount of its time is spent on postmarketing issues related, in part, to product safety. Two components of assuring a product's safety involve adverse event reporting (AER) and risk management plans, both of which were the focus of a presentation given at Harvard Medical School in early May 2012. In his presentation, Dr. Gerald Dal Pan...
  • Report: REMS Preventing Companies From Making Generic Medicines

    The Food and Drug Administration (FDA) Amendments Act of 2007 allowed FDA to institute risk management plans-known as Risk Evaluation and Mitigation Strategies (REMS)-for products with a high probability of misuse or dangerous side effects. Now, manufacturers of generic medicines are claiming a side effect of the REMS policy is just as dangerous: restrictive REMS policies are preventing them from obtaining samples of medicines they need to make generic copies. The ...
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    Considering Risk Evaluation and Mitigation Strategies (REMS)

    Every drug comes with some risk. The key issue for regulators, drugmakers, healthcare professionals and patients alike is whether the likely benefit is greater than the risk. This is the question reviewers at the US Food and Drug Administration (FDA) must grapple with in determining whether or not to approve a new product or to leave an already approved product on the market in light of new information about adverse events or other potential negative consequences. In some...
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    ClinicalTrials.gov: Requirements and Implementation Strategies

    The Food and Drug Administration Amendments Act of 2007 ( FDAAA ) established a requirement for certain clinical trials to be registered at trial initiation and to report summary results after trial completion in the public registry and results database called ClinicalTrials.gov . This law is intended to facilitate enrollment in clinical trials, allow for tracking of the progress of such trials and address problems with the lack of timely dissemination of research fi...
  • IOM Issues Report on Studying Safety of Approved Drugs

    The Institute of Medicines (IOM) has released a consensus report on ways to improve the US Food and Drug Administraiton's (FDA) oversight of the safety of already-approved drug products. The report, entitled Ethical and Scientific Issues in Studying the Safety of Approved Drugs , explores a paradox often faced by FDA: only products that are safe should be approved, but the true safety profile of a product is difficult to ascertain until it has been used in real-world co...
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    Regulatory Environment Changes Affect REMS

    To maintain the appropriate regulatory strategy for a product, it is important to stay abreast of continuing changes in the regulatory environment and applicable regulatory requirements. Knowing when regulatory requirements have changed because authorities have deemed an alternative to be sufficient to achieve the same goals can reduce wasted effort and costs for sponsors. One US Food and Drug Administration (FDA) requirement that has undergone an important change is th...
  • FDA-Backed Collaborative Research Fund Off to Slow, Controversial Start

    A fund established under the Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007 is beginning to ramp up activity after several years of cash-strapped stagnation, but not everyone is happy about the move, reports National Public Radio (NPR) . The Reagan-Udall Foundation was created under FDAAA to create an outlet for FDA, industry, academia and patient groups to come together to fund mutually beneficial activities. "The idea was that this foundation c...
  • New FDA Draft Guidance on DTC Television Advertisements

    The US Food and Drug Administration (FDA) released new draft guidance 12 March on how FDA intends to review TV advertisements before they are disseminated to the public. Guidance for Industry - Direct-to-Consumer Television Advertisements - FDAAA DTC Television Ad Pre-Dissemination Review Program "describes the types of TV ads that FDA intends to be subject to this provision, explains how FDA will notify sponsors that an ad is subject to the requirement of review under...
  • FDA Releases New Safety Communication Strategy

    The US Food and Drug Administration (FDA) released draft guidance on 8 March on how it intends to communicate with the public about drug safety issues, including important topics and emerging information. "The revised guidance describes the Center for Drug Evaluation and Research's (CDER's) single, standardized format for electronic drug safety communications about marketed drugs and provides information about the Center for Biologics Evaluation and Research's (CBER's) s...
  • FDA Releases Report on Postmarketing Study Requirements

    The US Food and Drug Administration (FDA) released a report 6 March on the postmarketing studies required of sponsors for products approved under the terms of the FDA Amendments Act (FDAAA) of 2007. The act allows FDA to mandate certain postmarketing requirements (PMRs) and postmarketing commitments (PMCs) of sponsors to further assess known risk, signals of serious risk or identify unknown risks. The report notes that the majority of PMRs (87%) and PMCs (75-80%) are o...
  • Politico: FDA Efforts to Create International Uniform Device Code Stalled by OMB

    Politico is reporting that efforts spearheaded by Congress five years ago to create a worldwide uniform device identification (UDI) system have stalled out in the regulatory process "for reasons that are unclear ." The unique identification system, mandated in 2007 under the Food and Drug Administration Amendments Act (FDAAA), was intended to standardize how medical devices are tracked. Congress envisioned a simple system similar to how groceries are scanned at a ch...